Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01734447
First received: November 22, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.


Condition Intervention Phase
Foetal Growth Problem
Small for Gestational Age
Drug: somatropin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray [ Designated as safety issue: No ]
  • Pubertal development, assessed according to Tanner method [ Designated as safety issue: No ]
  • Height velocity [ Designated as safety issue: No ]
  • Final height [ Designated as safety issue: No ]
  • Number of Adverse Events [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: April 2000
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.2, continuous treatment Drug: somatropin
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
Experimental: 1.2, non-continuous treatment Drug: somatropin
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
Experimental: 2.4, non-continuous treatment Drug: somatropin
2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients born with IUGR enrolled in trial GHRETARD/F/1/F
  • Bone age below 14 years in boys and 12 years in girls

Exclusion Criteria:

  • Bone age above 14 years in boys and 12 years in girls
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734447

Locations
France
Paris, France
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Catherine Boisson-Lesage, MD Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01734447     History of Changes
Other Study ID Numbers: GHRETARD/F/2/F
Study First Received: November 22, 2012
Last Updated: November 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014